Effect of Virtual Reality and Binaural Beat on Sleep and Comfort in Adults After Mechanical Valve Replacement Surgery (VR-BBS)

Zahraa Qasem Karem

Status: Completed

Conditions: Postoperative Patients Following Prosthetic Mechanical Valve Replacement, Focusing on Sleep Disturbances and Patient Discomfort

Treatments: Behavioral: VR + Binaural Beat Group; Other: Standard Postoperative care; Behavioral: Virtual Reality Relaxation; Behavioral: Binaural Beat Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07365488

24-18-Nov-2025 (Other Identifier)

VRBBS-MVR-SOUND-OF-THE- VALVE

Details and patient eligibility

About

This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery. Many patients experience sleep disturbances and discomfort due to the sound of the mechanical valve. Participants will be randomly assigned to one of two non-drug interventions to see which method improves sleep and reduces discomfort after surgery. The study aims to help improve recovery and comfort for patients after valve replacement.

Full description

This randomized clinical trial will evaluate the effects of four interventions on sleep disturbances and patient discomfort in adult patients after prosthetic mechanical valve replacement. Sleep disturbances are common due to the sound of the mechanical valve. Participants will be randomly assigned to one of four groups: (1) VR Group (2) Binaural Beat Group listening to binaural beats for 20 minutes (3) VR + Binaural Beat Group combining both interventions, and (4) Control Group receiving standard postoperative care without interventions. Primary outcomes include sleep quality and patient-reported discomfort measured during the early postoperative period. The study aims to identify which intervention or combination is most effective in improving recovery and patient comfort.

Enrollment: 140 patients

Sex: All

Ages: 28 to 71 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients will be eligible for participation following mechanical valve replacement surgery if they are willing to participate, able to provide informed consent, and meet the following criteria: male or female aged 18 years or older, hemodynamically stable, oriented and conscious without cognitive impairment, free from visual or auditory impairments, able to communicate orally in Arabic, not receiving analgesics or sedatives within at least four hours prior to the intervention, and having no history of epilepsy, seizure disorders, or recurrent migraines.

Exclusion criteria

• The study's exclusion criteria will include participants with facial or head injuries, a history of vertigo or severe motion sickness, immediate postoperative cardiac arrest, the use of hypnotic medications, the presence of a tracheostomy, or any implanted body hardware.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

VR Group

Experimental group

Description:

Guided VR relaxation sessions

Treatment:

Behavioral: Virtual Reality Relaxation

Binaural Beat Group

Experimental group

Description:

sessions BBS for reducing discomfort and enhance sleep quality

Treatment:

Behavioral: Binaural Beat Stimulation

VR + Binaural Beat Group

Experimental group

Description:

Combined VR \& BBS sessions

Treatment:

Behavioral: VR + Binaural Beat Group

Control Group

Other group

Description:

Standard postoperative care

Treatment:

Other: Standard Postoperative care